Savara Introduces aPAP ClearPath™, a GM-CSF Autoantibody Blood Test to Detect Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Rhea-AI Summary

Savara Inc. (Nasdaq: SVRA) has launched a new serum-based blood test, aPAP ClearPath™, for physicians in the U.S. to diagnose a rare autoimmune lung disease. The test is highly sensitive and specific, targeting GM-CSF autoantibodies, with an estimated diagnosed prevalence of seven cases per million in the U.S. The Company has partnered with Trillium Health to develop the test and has also launched a disease awareness campaign.

Insights

Medical Research Analyst

The introduction of Savara Inc.'s aPAP ClearPath™ test represents a significant development in the diagnosis and management of autoimmune pulmonary alveolar proteinosis (aPAP). The test's sensitivity and specificity are crucial in accurately identifying the presence of GM-CSF autoantibodies, which are indicative of aPAP. The partnership with Trillium Health, a CLIA-certified lab, underscores the test's credibility and reliability.

From a medical research perspective, early and definitive diagnosis is paramount in improving patient outcomes. This test could reduce the diagnostic odyssey for patients with aPAP, potentially leading to earlier treatment interventions. The disease awareness campaign is also a strategic move to enhance early detection rates, which can translate into better disease management and patient prognosis.

The economic implications for Savara Inc. could be substantial, considering the rarity of the disease and the lack of competitive diagnostic tools. The test may become a standard of care for aPAP, potentially creating a steady revenue stream for the company. However, the market size is limited by the low prevalence of the disease. Stakeholders should monitor adoption rates and insurance coverage decisions, which will impact the test's financial success.

Healthcare Industry Analyst

The launch of the aPAP ClearPath™ test by Savara Inc. aligns with the growing trend in the healthcare industry towards personalized medicine and precision diagnostics. The noninvasive nature of the test and its no-cost appeal to physicians could disrupt current diagnostic practices for aPAP and influence the competitive landscape.

As an industry analyst, it is important to consider the strategic implications of such a launch. Savara Inc.'s decision to offer the test at no cost initially may be a market penetration strategy designed to establish the test as the gold standard for aPAP diagnosis. However, this raises questions about the long-term business model and reimbursement strategies that will be employed once the test gains market traction.

The partnership with Trillium Health may open additional channels for market expansion and could signal future collaborations. The test's impact on the stock market will depend on its market uptake, the success of the awareness campaign and subsequent revenue generation. Investors will be keen to observe how this product contributes to Savara Inc.'s overall portfolio and growth trajectory.

Financial Analyst

For investors, the launch of aPAP ClearPath™ by Savara Inc. could be seen as a strategic initiative to diversify its product offerings and penetrate a niche market. The test's introduction may not immediately reflect on the company's financials, but it has the potential to generate long-term value if it becomes the preferred diagnostic tool for aPAP.

It is important to analyze the cost structure associated with the development and distribution of the test, as well as the potential revenue model post-introduction phase. The partnership with Trillium Health suggests a shared investment, which may mitigate some of the financial risks for Savara Inc.

Investors should consider the scalability of the test and the potential for international expansion, given the global prevalence of the condition. The rarity of aPAP could limit revenue potential, but exclusivity and lack of competition may justify the investment. Close attention should be paid to quarterly financial reports for indications of the test's market performance and contribution to the company's bottom line.

• The simple, no-cost, and noninvasive test is now available to physicians in the U.S.

• Company launches campaign in the U.S. to raise awareness of the rare autoimmune lung disease and need for early testing

LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, recently launched aPAP ClearPath™, a new serum-based blood test that can be used by physicians in the U.S. to obtain a definitive diagnosis of aPAP, a rare autoimmune lung disease mediated by autoantibodies targeting GM-CSF. Autoimmune PAP accounts for approximately 90% of all patients with PAP and has an estimated diagnosed prevalence of seven cases per million in the U.S. and similar or higher prevalence reported elsewhere in the world.

The aPAP ClearPath™ test is a highly sensitive and specific quantitative immunoassay designed to detect aPAP GM-CSF autoantibodies in human serum. The Company partnered with Trillium Health (trillium-health.com), a modern health solutions provider and a Clinical Laboratory Improvement Amendments (CLIA)-certified lab, to develop the simple, no-cost, and noninvasive test. A supporting disease awareness campaign was also launched to improve understanding of aPAP, highlight the hallmark signs and symptoms of the disease, and educate physicians about the need for early testing.

“Our strong operational focus continues as we deliver on our goal of introducing a laboratory-based GM-CSF autoantibody blood test in the U.S. by the end of the year,” said Matt Pauls, Chair and CEO, Savara. “Our commitment to the patient community is underscored by the introduction of this simple, no-cost blood test that U.S. physicians can use to confirm or rule out aPAP. With a few thousand diagnosed patients in the U.S., we suspect the true prevalence of aPAP may be underestimated and, similar to other rare diseases, the introduction of a diagnostic could help decrease the time to diagnosis and increase diagnosed prevalence.”

“Education and widespread blood testing for aPAP is a critical step in shortening the time to diagnosis for patients with aPAP, helping to avoid misdiagnoses and more costly and invasive diagnostic procedures,” said Ali Ataya, M.D., Associate Professor of Medicine, University of Florida, Division of Pulmonary and Critical Care Medicine. “I congratulate Savara for making this simple test broadly available for physicians in the U.S.”

Only a physician or healthcare provider can make a diagnosis of aPAP. To learn more about aPAP ClearPath™, the importance of early testing for aPAP, and to order a test kit, please visit www.apapclearpath.com.

The Company expects to roll out a healthcare provider disease awareness campaign and GM-CSF autoantibody blood test in Europe next year.

About aPAP

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant sediment in the alveoli (or air sacs) of the lungs. The surfactant consists of proteins and lipids and is an important physiological substance that lines the inside of the alveoli to prevent the lungs from collapsing. In a healthy lung, the old and inactivated surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering the macrophages unable to perform their tasks. As a result, an excess of surfactant accumulates in the alveoli, causing obstruction of gas exchange, and patients start to experience shortness of breath, often with cough and frequent fatigue. Patients may also experience chronic cough, as well as episodes of fever, chest pain, or coughing blood, especially if secondary lung infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow^® Nebulizer System (PARI Pharma GmbH). Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com. (X, formerly known as Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).

Forward-Looking Statements

Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the estimated prevalence of aPAP and the suspicion it may be underestimated, the potential benefits and impact of aPAP ClearPath™ and aPAP education, including on the time to diagnosis and diagnosed prevalence, and the expected timing of the disease awareness campaign and autoantibody blood test in Europe. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the degree to which aPAP ClearPath™ is accepted and used by healthcare providers, disruptions or inefficiencies in the supply chain and geopolitical conditions on our business and operations, the outcome of our ongoing and planned clinical trials for our product candidate, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to successfully develop our product candidate, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as molgramostim that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231221923423/en/

Savara Inc. IR & PR

Anne Erickson (anne.erickson@savarapharma.com)

(512) 851-1366

Source: Savara Inc.

FAQ

What is the new blood test launched by Savara Inc. (Nasdaq: SVRA)?

Savara Inc. (Nasdaq: SVRA) has launched a new serum-based blood test called aPAP ClearPath™ for diagnosing a rare autoimmune lung disease.

What is the estimated diagnosed prevalence of the rare autoimmune lung disease in the U.S.?

The estimated diagnosed prevalence of the rare autoimmune lung disease in the U.S. is seven cases per million.

Who did Savara Inc. (Nasdaq: SVRA) partner with to develop the new blood test?

Savara Inc. (Nasdaq: SVRA) partnered with Trillium Health to develop the new blood test.

What is the focus of the disease awareness campaign launched by Savara Inc. (Nasdaq: SVRA)?

The disease awareness campaign launched by Savara Inc. (Nasdaq: SVRA) aims to improve understanding of the rare autoimmune lung disease, highlight its signs and symptoms, and educate physicians.